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Managed Care Newsstand
U.S. Sens. Jeanne Shaheen, D-N.H., Rob Portman, R-Ohio, and Sheldon Whitehouse, R-R.I., introduced the bipartisan Comprehensive Addiction and Recovery Act (CARA) 3.0 to help combat the opioid epidemic, which has been exacerbated by the COVID-19 pandemic. The bill increases the funding authorization levels for the CARA programs enacted in 2016. The bipartisan national e ort as desi ned to ensure that federal resources were devoted to evidence-based education, treatment, and recovery programs that work. CARA programs were funded at $782 million in 2021. Several key provisions of CARA 2.0 were enacted as part of the SUPPORT Act on Oct. 24, 2018. CARA 3.0 builds on these e orts by increasin the undin authorization levels and laying out new policy reforms to strengthen the federal government’s response to this crisis (e.g., it permanently allows providers to prescribe medication-assisted treatment via audio-only telehealth).
New X-Waiver Guidelines Issued
The Department of Health and Human Services (HHS) issued new practice guidelines as it looks for ways to address the opioid epidemic. The new guidelines are slightly different from those issued under the Trump administration, which were rescinded in January. Physicians, nurse practitioners, physician assistants, clinical nurse must enroll in the CAF program and submit uncovered claims for vaccines administered on or after Dec. 14, 2020. Prior to submitting claims for reimbursement under the program, providers are required to bill the patient’s health plan and recei e confirmation that accine administration is not covered or includes patient cost-sharing.
specialists, certified nurse anesthetists, and certified nurse midwives may now treat up to 30 patients with buprenorphine under a waiver established under the new guidance. Providers will still need to submit notice of their intention to prescribe buprenorphine to the Substance Abuse and Mental Health Services Administration, but they will now be exempted from training requirements.
GAO Reports on Behavioral Health During the COVID-19 Pandemic
The U.S. Government Accountability O ce ( O) recently released a report on issues related to the demand for behavioral health, coverage and payment for these services, and how they have changed during the COVID-19 pandemic. The report, the result of a request made by Sen. Ron Wyden, D-Ore., last year, describes: (1) what is known about the need for and availability of behavioral health services and how these have changed during the COVID-19 pandemic; and (2) what issues selected sta eholders identified re ardin the payment of claims for behavioral health ser ices Key findin s ocus on workforce shortage, denials and delay of payment, and parity issues.
HRSA Implements COVID-19 Coverage Assistance Fund
On May 3, the Health Resources and Services Administration (HRSA) announced a new program covering the cost of administering COVID-19 vaccines to patients enrolled in health plans that either do not cover vaccination fees or cover them with patient cost-sharing. This new program is called the HRSA COVID-19 Coverage Assistance Fund (CAF). Providers
House Committees Hold Hearings on Drug-Pricing Legislation
The House Committee on Energy and Commerce and the House Committee on Education and Labor held hearings on major drug pricing legislation on May 4 and 5 with the hopes of bringing the bill to the oor in the comin ee s House emocratic and Republican leaders filed separate bills that were similar in scope to the bills introduced in the last Congress. The Democratic bill, HR3, passed the House in late 2019 nearly along party lines. The Republican bill, HR19, the counter to the Democratic bill, did not receive a vote in the last Congress. The Senate Committee on Finance passed its own drug-pricing bill in 2019, but that bill ne er made it to the oor he emocratic bill calls for government negotiation of high-cost drugs that have little or no competition. The bill also proposes a edicare in ation rebate amon the many other provisions. Both bills call for capping out-of-pocket costs for Part D beneficiaries and eliminatin the co era e ap in the Part benefit, but they di er on payment responsibilities in the catastrophic phase; the Democratic bill calls for drug manufacturers to bear a greater share of the cost burden in this phase. Witnesses at the hearing said these Part D redesign proposals would do little to control costs but would likely increase premiums and overall program costs he Con ressional ud et O ce (CBO) estimates that HR3 would save
$450 billion over a 10-year period. The Democratic proposal would use most of those savings to provide dental, hearing, and ision benefits under edicare
Following the hearing, a number of Democratic House members have expressed concern over the bill. Recent media reports suggest that as many as eight to 10 Democrats may not support the bill. Democrats hold a six-seat majority and can lose few Democratic members if most — if not all — Republicans oppose the bill. Negotiations are likely to continue in the coming weeks to try and shore up Democratic support for the bill. If it passes, it faces an unlikely future in the Senate. The Senate failed to take up HR3 in 2020 when the Republicans controlled the chamber. Democrats now hold the majority, but the Senate is evenly divided at 50-50, so the bill will likely require all Democratic senators to support it. At this point, passage of a major drug-pricing bill appears unlikely, but the recent hearings and legislative action suggest that drug-pricing will remain a si nificant issue ithin Con ress over the coming years.
House Votes on a Package of Mental Health Bills
The U.S. House voted on a package of 14 mental health bills on May 12. The bills included increased authorization of funding for the National Suicide Prevention Lifeline and funding to conduct a suicide prevention media campaign. Other bills included funding directed to improving suicide awareness in emergency medical facilities and funding to support school-based awareness campaigns. The 988 Suicide Prevention Lifeline is expected to be in place by July 2022. Additional bills included block grants to support individual wellness programs for those involved in communitybased or anizations and first responders who deal with addiction and mental health issues, as well as funding for school-based mental health services. The package of bills has broad support. It is not clear when the Senate may take up the legislation, but it is expected that the package of bills will pass Congress at some point this year.
President Biden Releases FY2022 Budget
On May 28, President Joe Biden released a trillion proposed bud et or fiscal year 2022. The proposal, which is expected to undergo many changes before being signed into law, presents a significant increase in federal spending and includes si nificant in estments in President Biden’s top priorities, including infrastructure, education, research, public health, paid family leave, and child care.
The budget also calls on Congress to act “to further strengthen healthcare by lowering prescription drug costs and expanding and improving health coverage.” The president’s healthcare agenda includes cutting prescription drug costs by letting Medicare negotiate prices, reducing deductibles or ordable Care ct ( C ) marketplace plans, improving Medicare benefits, creatin a public option and i ing people age 60 and older the option to enroll in Medicare, and closing the Medicaid coverage gap to help millions of uninsured Americans gain health insurance.
FDA Announces New Drug Supply Chain Guidance
On June 3, the U.S. Food and Drug Administration (FDA) announced two new finalized and t o dra t uidance documents to further enhance the security of prescription drugs in the U.S. supply chain ia proper identification and trac ing. The guidance documents lay out the FDA’s recommendations for compliance with applicable Drug Supply Chain Security Act (DSCSA) requirements, including those for enhanced drug distribution security at the package level that go into e ect in o ember
On June 8, the Biden-Harris administration announced its ey findin s rom the reviews directed under a February Executive Order on America’s Supply Chains, as well as immediate actions the administration will take to strengthen American supply chains to promote economic security, national security, and good-paying union jobs. The administration has called on HHS and other agencies to:
• Establish a public-private consortium — leveraging the Defense
Production Act (DPA) and existing partnerships — to bolster the production of critical drugs on
U.S. soil. • Invest around $60 million from the
DPA appropriation in the American
Rescue Plan to create “novel platform technologies” for domestic active pharmaceutical ingredient (API) production. • Increase funding of advanced manufacturing technologies for drug and API production.
HHS Looks to Rescind Insulin Rule
The U.S. Department of Health and Human Services (HHS) is proposing to rescind the Trump administration drug rule that required community health centers to pass on all their insulin and epinephrine discount savings to patients. The proposal to retract the rule is under re ie at the hite House O ce of Management and Budget (OMB). Once it clears OMB, HHS can publish it at any time. The rule was previously delayed until July 20, 2021.
